Effects of Walking Analysis on Surgical Outcomes

Phase 2

Completed

• Conditions: Cerebral Palsy
• Interventions: Procedure: Surgery with gait analysis report; Procedure: Surgery without gait analysis report

• Registration Number: NCT00114075
• Lead Sponsor: Agency for Healthcare Research and Quality (AHRQ)

Brief Summary

The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.

Detailed Description

Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.

Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-06-13
• Study First Submitted QC: 2005-06-13
• Study First Posted: 2005-06-14
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-08
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Diagnosis of cerebral palsy
• Able to walk
• Under evaluation for orthopedic surgery to correct walking problem(s)

Exclusion Criteria

• Orthopaedic surgery in past 1 year
• Injection of botulinum toxin in past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait analysis	Surgery with gait analysis report	Gait analysis report is available for treatment planning
Control	Surgery without gait analysis report	Subject has gait analysis test, but report is not available for treatment planning

Primary Outcome Measures

Name	Time	Method
Change in walking ability at 1 year	1 year
Change in walking efficiency at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
Change in gross motor function at 1 year	1 year
Change in quality of life at 1 year	1 year
Additional treatment needed at 1 year	1 year

Trial Locations

Locations (2)

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Shriners Hospital for Children, Los Angeles; 🇺🇸 Los Angeles, California, United States